Understanding Japanese Medical Device Requirements - PDF document

Understanding Japanese Medical Device Requirements Atsushi Tamura, Ph. D.PMDA, JAPANSeoul, KOREAJuly 4~5, 2011 2011 AHC Workshop on Medical Devices: “Implementation of GHTF Documents ” Pharmaceutical Affairs Law (PAL) Pharmaceutical Affairs Law (PAL) covers regulations on pharmaceuticals, medical devices and cosmetics. Under the PAL, the Minister of Health, Labour and Welfare has the authority to

give an marketing approval to issue a license for marketing authorization holderto issue a manufacturer license 2 Key pharmaceutical legislation Pharmaceutical Affairs Law (PAL, 1960)Cabinet Ordinance on PAL, 1961 Cabinet Ordinance on PAFSC, 2000 Ministerial Ordinance on PAL, 1961GCP for pharmaceuticals, 1997, for MD, 2005Good Vigilance Practice (GVP), 2004 Good Quality Practice (GQP), 2004 etc. Essen

tial PrinciplesCertification standards for class II devicesClassification of medical devices List of orphan designation etc. Information on application procedures Guidelines for clinical evaluation etc. Law Cabinet Ordinance Ministerial OrdinanceB Ministerial Notification Notification 3 Authorities of MD regulation MHLWMinisterJurisdict

ion over PAL PMDAApproval review PMSM MarketingAuthorizationHolder (MAH) Manufacturer Product(Class III,IV) Product(Class II) CertificationBodies Certification Approval Manufacturer(Specified Biological Product etc.) Manufacturer’sLicense Manufacturer’sLicense MAH’s License Local Governments RegionalBureaus Registration cooperation 4 Imperial palace Ministry of Health Labor & Welfare (MHLW) &

Pharmaceuticals & Medical Devices Agency (PMDA) Diet 5 10 min. walk Shared Responsibilities [MHLW] Ultimate Responsibilities in policies & administrative measuresex. Final judgment on approvalProduct withdrawal from market [PMDA] “TECHNICAL ARM of MHLW” Actual review, examination, data analysis, etc. to assist MHLW’S measuresex. Approval Review of MDsQMS/GLP/GCP inspectionCollection and an

alysis of Adverse Event Reports Prerequisites to bring MDs intotheJapanese MarketMinister’s Approval shonin(Art.14)or 3rd party Certification ninsho(Art.232) or Marketing Notification todokede(Art.14 License for Marketing Authorization Holder Seizohanbaigyokyoka(Art.12) License for Manufacturer seizogyokyoka(Art. 13)or Status as Recognized Foreign Manufacturer gaikokuseizogyosya

nintei(Art. 133) Product Company Plant Medical Devices Regulation of Japan, EU and US:Notified Body Certification (All Medical Devices) Japan:Third Party Certification(Low Risk Medical Devices)Minister’s Approval on basis of PMDA review (High Risk Medical Devices)US FDA : Approval or Premarket Clearance(Note) under pilot study of Third Party review system for some low risk medical devices GHTF Class

ificationClass extremely low riskRay filmClass low riskMRI, digestive cathetersClass medium riskartificial bones, dialyzerClasshigh riskpacemaker, artificial heart valves PAL classificationCategoryPremarket regulationJapanese MD NomenclatureGeneral MDs(Class I)Self declaration1,195Controlled MDs(class II)Third party Certification1,788(910 for Party)Specially Controlled MDs(class III & IV)Minister’s App

roval(MHLW Ministerial Notification No.298, July 20, 2004 ) Overview of Classification and Premarket Regulation for Medical Devices Third Party Notification Process Conformity toEssential PrinciplesPerformance Std.sRisk ManagementLabeling, PackageInsert, etc2. Conformity to Quality AssuranceStds Certifying Body Evaluation ISO13485 Objection Applicant(Marketing Authorization Holder MHLW(1) Application(2)

Certification(4) Followup Inspection(3) Certified Product Report 10 Medical Device Approval Process PMDA ApplicationApproval Review againstEssential Principles STED (SummaryData Subsets Reliability ReviewData Reliability GLP ,GCP, GMP (Class IV)ConformityPost Approval Inspection ManufacturingFacilities ApplicantSite, Document MHLW 11 Review System of PMDA For faster approval Clinical trial consultation Ap

proval review Laboratory studies Clinical studies Application for approval Effective review= Time reduction before submission Laboratory studies Clinical studies Application for approval ApprovalPriority consultation= Time reduction before initiation of a clinical trial Approval 12 What is necessary to be thought when cooking?Taste?Amount?Calorie?Easiness to eat?Timing?To whom?Main IngredientCuisineMeal Typ

eSpecialty CollectionsHolidays & OccasionsCooking Method What is necessary to be thought when you make medical devices?SafetyPerformance/EffectivenessQualityTo provide a comprehensive list of design and manufacturing requirementssafety and performance, some of which are relevant to each medical device. Essential PrinciplesSix general requirementsof safety and performance that apply to all medical devicesA c

omprehensive list of design and manufacturingrequirementsSome of whichare relevant to each medical device General Requirements1. Medical devices should be designed and manufactured in such a way that, when usedunder the conditions and for the purposes intended and, where applicable, by virtue ofthe technical knowledge, experience, education or training of intended users, they willnot compromise the clinical

condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. General Requirements2. The solutions adopted by the manufacturer for the design and manu

facture of the devices should conform to safety principles, taking account of the generally acknowledged state of the art. When risk reduction is required, the manufacturer should control the risk(s) so that the residual risk(s) associated with each hazard is judged acceptable. The manufacturer should apply the following principles in the priority order listed:identify known or foreseeable hazards and estim

ate the associated risks arising from the intended use and foreseeable misuse,eliminate risks as far as reasonably practicable through inherently safe design and manufacture,reduce as far as is reasonably practicable the remaining risks by taking adequate protection measures, including alarms,inform users of any residual risks. General Requirements3. Devices should achieve the performance intended by the ma

nufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions within the scope of the definition of a medical device applicable in each jurisdiction. General Requirements4. The characteristics and performances referred to in Clauses 5.1, 5.2 and 5.3 should not be adversely affected to such a degree that the health or safety of the patient or the

user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer’s instructions. General Requirements5. The devices should be designed, manufactured and packed in such a way that

their characteristics and performances during their intended use will not be adversely affected under transport and storage conditions (for example, fluctuations of temperature and humidity) taking account of the instructions and information provided by the manufacturer. General Requirements6. The benefits must be determined to outweigh any undesirable side effects for the performances intended. These desi

gn and manufacturing requirements are grouped as:Chemical, physical and biological properties.Infection and microbial contamination.Manufacturing and environmental properties.Devices with a diagnostic or measuring function.Protection against radiation.Requirements for medical devices connected to or equipped with an energy source.Protection against mechanical risks.Protection against the risks posed to the

patient by supplied energy or substances.Protection against the risks posed to the patient for devices for selftesting or selfadministration.Information supplied by the manufacturer.Performance evaluation including, where appropriate, clinical evaluation. Application DossierGHTFbased STED is required.Essential Principles from GHTF was introduced in Japanese regulation (PAL Art.41(3)) and any device shall be

in conformity with the EPs.See Notification by DGPFSB, Yakusyokuhatsu#0216002, February 16, 2005 Notification by Director, OMDE, Yakusyokukihatsu#0216001, February 16, 2005 Notification by Director, OMDE, Yakusyokukihatsu#0216003, February 16, 2005http://www.pmda.go.jp/operations/shonin/info/iryokiki/iryokikilist.html (Japanese) Application Form(Form223 of Ministerial Ordinance on PAL) STED Data set Decla

ration of Conformity with EP Set of Application Documents (Image)In case of High Risk exclude GMP conformity assessment Request for reliability of GCP/GLPRequest for compliance to GMP(ISO13485)Shonin Shinsei Syo Attachments Origin or history until discovery and regulatory status in foreign countriesReason/background forspecificationC. Stability & EnduranceD. Document for compatibility with Essential Pri

ncipleE. PerformanceF. Risk AnalysisG. Manufacturing (Process, QC, Sterilization)H. Clinical Data STED(Gaiyo) Device Overview Essential principle & Evidence of conformity Device descriptionSummary of preclinical design verification and validation Labeling (Draft) Risk analysis Manufacturing info. Shonin Documents CategoryName Purpose of use, Efficacy/Shape, Structure or PrincipleRaw materials or compone

nts Specifications Operation for use/ProcedureManufacturing ProcessStorage or UBD Site for Manufacturing manufacturing site for Raw material Remarks: Package Insert etc 24 CONTENTS OF THE STEDEssential Principles (EP) Checklist The STED should contain an EP checklist that identifies:the Essential Principles;whether each Essential Principle applies to the device and if not, why not;the method(s) used to dem

onstrate conformity with each Essential Principle that applies; a reference for the method(s) employed (e.g., standard), andthe precise identity of the controlled document(s) that offers evidence of conformity with each method used. 25 CONTENTS OF THE STED Essential Principles (EP) Checklist Methods used to demonstrate conformity may include one or more of the following:conformity with recognised or other

standards;conformity with a commonly accepted industry test method(s); conformity with an inhouse test method(s);the evaluation of preclinical and clinical evidence. comparison to a similar device already available on the market. 26 CONTENTS OF THE STED Essential Principles (EP) Checklist The EP checklist should incorporate a crossreference to the location of such evidence both within the full technical do

cumentation held by the manufacturer and within the STED (when such documentation is specifically required for inclusion in the Summary Technical Documentation as outlined in this guidance). See GHTF/SG1/N044:2008 Role of Standards in the Assessment of Medical DevicesSee GHTF/SG5 guidance documents Summary Technical Documentation (STED)GHTF STED is mandatory usingUsing GHTF Essential Principles (EPs) Confor

mity assessment providing the Check List for EPs providing the Technical Standard (TS)TS required International Standard or well used guidance documents(Those slides originally made by Hiroshi Ishikawa, JFMDA) How the STED may differ by classification ? Application Form 22“ Shonin Shinsei Syo ” TenpuShiryo “ STED Data Sub Set Application Form 64“ Ninshou Shinsei Syo ” Request for

GMP Conformity Assessment 25“ Tekigousei Cyousa “ Third Party PMDA Third Party Local Government Binding No need If provided TS What is Technical Standard ? JISTranslated International Standard or other recognized standard, whichever used as internationally. Translated in JapaneseSuch as IEC or ISO: IEC60601, ISO13485, 14971 If there is no such standard, then alternatively using Guidance Docu

ments which NCA issues or Industry Standard such as NEMA Standard etc. 30 Conformity Assessment Technical Standard382 Standards have been established.So far 382 new application for MDs and 18 for IVDs are certified by Third Party.Technical Standards for conformity assessment handled by Third Partyall of Class II JMDN1785 items# of existing MDs783 items# of TR for EPitems 44% of Class II JMDN items are cover

ed! # of TR for High risk 17 items Examples for Third Party Certification Using Standards CT RaySystem Example of Medical Devices Dental Units Individual Standard Basic StandardGeneral Requirements Conformity Assessment Technical Standard(Article 23 INDIVIDUALSTANDARDIf it is essential INDIVIDUALSTANDARDIf it is essential VERTICALSTANDARDJIS Z etc VERTICALSTANDARDJIS T 5701Etc HORIZONTALSTANDARDJIST060

11 JIS T 09931 etc Rule of general principalJIST4701etc Essential Principles Article 41 Summary The evidence and procedures the manufacturer may use to demonstrate a medical device is safe and performs as intended. The elements that should apply to each class of device such that regulatory demands increase with classification. The process that the RA or CAB may confirm elements are correctly applied by th

e manufacturer. The manufacturers written declaration that it has correctly applied the elements relevant to the device.��GHTF SG1 Workshop Conformity Assessment Requirements Future DirectionMHLW and PMDA will continue to work with industry to deliver innovative medical devices quickly to patients according to the Strategy. Good communication and collaboration are key to success! Thank you! 3